Cholecystitis, AcuteVERTNCT04922528
Visualization of the Extrahepatic biliaRy Tree Trial
A study testing Laparoscopic Cholecystectomy with Fluorescent Cholangiography and Laparoscopic Cholecystectomy with White Light Imaging in people with Cholecystitis, Acute and Acute Cholangitis, run by University of British Columbia at 1 site in Canada.
Trial summary
This study is a prospective randomized controlled trial evaluating the use of a fluorescent dye, indocyanine green (ICG), in the identification of important bile duct anatomy during emergent same-admission cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystitis, Acute, Acute Cholangitis, Gallstone Pancreatitis
- What is being tested?
- Laparoscopic Cholecystectomy with Fluorescent Cholangiography and Laparoscopic Cholecystectomy with White Light Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2021to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission or consultation by the Acute Care Surgery (ACS) service
- Diagnosis of acute biliary disease requiring index laparoscopic cholecystectomy
- Diagnoses of acute cholangitis, choledocholithiasis, and gall stone pancreatitis may be included. However, they must have cleared ducts confirmed via endoscopic ultrasound, ultrasound, ERCP, and/or laboratory investigations.
- Ability to understand and follow study procedures and protocols, and provide signed informed consent.
Who cannot join
- Female patients who are pregnant or currently breastfeeding
- Known pre-existing liver disease, including cirrhosis
- Known allergy to iodine or shellfish
- Known allergy to indocyanine green (ICG)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Jean Philip Dawe, CD MD FRCSC, 6048755094, philip.dawe@vch.ca
Karan J D'Souza, MD MPH MM, 6048755094, karan.dsouza@alumni.ubc.ca
About this study
Official title: Evaluate the Efficacy of ICG Fluorescent Cholangiography for Visualization of Extrahepatic Biliary Anatomy in Emergency Cholecystectomy: A Single-Center, Randomized, Controlled, Parallel-Group Study
This study is a prospective randomized controlled trial evaluating the use of a fluorescent dye, indocyanine green (ICG), in the identification of important bile duct anatomy during emergent same-admission cholecystectomy. Participants will be randomized into either the control arm, which uses the standard of care white light during laparoscopy or the intervention arm, which will use ICG fluorescent cholangiography as an adjunct to white light to visualize the biliary anatomy. The investigators hypothesize that the use of fluorescent cholangiography will increase the rates of identification of important biliary anatomy during laparoscopic cholecystectomy. The effectiveness, feasibility, and safety will be compared between the two groups using a post-operative survey form the surgeons will complete prior to exiting the operating room.
Read the detailed description
Near-infrared fluorescent imaging techniques have shown promise in aiding to delineate and visualize extrahepatic biliary structures. Indocyanine green (ICG) is a water-soluble fluorescent dye that has been shown to improve visualization of biliary anatomy under fluorescent cholangiography. The standard of care for many acute biliary disease conditions, such as acute cholecystitis, remains early laparoscopic cholecystectomy. Even though real-time fluorescent cholangiography using ICG has the potential to enhance the visualization of biliary structures and anatomy, and therefore reduce the risk for bile duct injury, the majority of the studies published to date exclude acute biliary disease patients. The pathophysiology of acute biliary disease processes is associated with inflammation and adhesions that increase the challenge of achieving a critical view of safety. The investigators propose that using ICG and fluorescent cholangiography near-infrared imaging techniques as an adjunct in acute care laparoscopic cholecystectomies has the potential to help mitigate the increased risk of bile duct injury by increasing extrahepatic biliary structure detection and surgeon confidence.
Eligible patients will be identified through their initial clinical evaluation, which will be verified by the patient's primary surgeon. If and once a patient has been confirmed as eligible, the surgeon or designate will introduce the clinical trial design in detail. If after being introduced to the study and having had the opportunity to ask questions, the patient is willing to participate, the patient will be asked to review and sign the informed consent document.
Upon entry into the clinical trial, the allocation sequence will be generated using a block randomization schema with computer-generated random numbers in a 1:1 ratio, with block sizes of 4 by a co-investigator with no clinical involvement in the trial. The same co-investigator will prepare sequentially numbered, opaque, sealed and stapled envelopes and stored them in a locked cabinet in the operating room control desk. Each envelope contained instructions for the arm the participant had been randomly assigned to, either treatment (ICG cholangiography) or control (standard white light only) arms. After the research team member has obtained the participant's consent, the surgeon or designates will obtain the next consecutively numbered envelope and proceed to open it after the patient is anesthetized and prior to beginning the surgery.
The patient will be blinded to the result of the randomization until after surgery as the envelope will be opened only after the patient has received their general anesthetic. No blinding of the surgical team, research team members or outcomes assessors will be used in this study given the procedural nature and acute condition of the patients included.
- Conditions
- Cholecystitis, Acute, Acute Cholangitis, Gallstone Pancreatitis, Choledocholithiasis, Cholecystolithiasis, Gallbladder Diseases
- Being tested
- Laparoscopic Cholecystectomy with Fluorescent Cholangiography, Laparoscopic Cholecystectomy with White Light Imaging
- Keywords
- Cholangiography, Indocyanine green, ICG, Fluorescent cholangiography, Biliary Anatomy
- Medical subject headings
- Cholecystitis, Acute, Choledocholithiasis, Cholecystolithiasis, Gallbladder Diseases, Biliary Tract Diseases, Digestive System Diseases, Calculi, Pathological Conditions, Anatomical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Cholecystectomy with Fluorescent CholangiographyProcedure or surgery
Indocyanine green is a fluorophore molecule which is metabolized by the liver and excreted exclusively through the biliary system. Intra-operatively, near-infared imaging via the laparoscope will be used to visualize the biliary anatomy in the intervention arm, as an adjunct to standard of care white-light imaging.
Laparoscopic Cholecystectomy with White Light ImagingProcedure or surgery
As per the current standard of care, patients undergoing laparoscopic cholecystectomies will have it completed using white light imaging through the laparoscope.
| Study group | Role | What they receive |
|---|---|---|
| Near-Infrared Fluorescence Cholangiography | Experimental | Standard laparoscopic cholecystectomy completed with a combination of white light imaging and near-Infrared fluorescence cholangiography after administering 5 mg of a 25 mg/10 mL solution of indocyanine green (ICG) intravenously prior to the operation Receives: Procedure: Laparoscopic Cholecystectomy with Fluorescent Cholangiography; Procedure: Laparoscopic Cholecystectomy with White Light Imaging |
| White Light Imaging | Active comparator | Standard laparoscopic cholecystectomy completed with only standard white light imaging only Receives: Procedure: Laparoscopic Cholecystectomy with White Light Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of extrahepatic biliary structures
The extrahepatic biliary structures which we will be assessing the identification of include: Cystic Duct (CD), Right Hepatic Duct (RHD), Common Hepatic Duct (CHD), Common Bile Duct (CBD), Cystic Duct - Gall Bladder junction (CD-GB), and Cystic Duct - Common Bile Duct junction (CD-CBD).
Measured: Intraoperatively
Secondary outcomes (4)
Operative success
Rates of laparoscopic subtotal cholecystectomy and laparoscopic cholecystostomy tube placement.
Measured: Intraoperatively
Rates of conversion
Rate of conversion to open cholecystectomy.
Measured: Intraoperatively
Operative time
From the time of opening the skin to the time of closure.
Measured: Intraoperatively
Surgeon satisfaction
Operating surgeons satisfaction (as rated by post-procedural survey) with the utility and feasibility of the modality.
Measured: Through participant discharge, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study startAug 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cholecystitis, AcuteStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention and comparator arms will be ran in parallel, with a block randomization sequence determining the participants allocations.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Dawe, University of British Columbia
- Investigators
- Jean Philip Dawe, CD MD FRCSC, Principal investigator, Clinical Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922528
- Sponsor's protocol ID
- H21-01375
- Acronym
- VERT
- Status last verified
- Jun 2021
- First submitted
- 31 May 2021
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zroback C, Chow G, Meneghetti A, Warnock G, Meloche M, Chiu CJ, Panton ON. Fluorescent cholangiography in laparoscopic cholecystectomy: the initial Canadian experience. Am J Surg. 2016 May;211(5):933-7. doi: 10.1016/j.amjsurg.2016.01.013. Epub 2016 Feb 23.
PubMed 27151917Bleszynski MS, DeGirolamo KM, Meneghetti AT, Chiu CJ, Panton ON. Fluorescent Cholangiography in Laparoscopic Cholecystectomy: An Updated Canadian Experience. Surg Innov. 2020 Feb;27(1):38-43. doi: 10.1177/1553350619885792. Epub 2019 Nov 19.
PubMed 31744398
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficacy of ICG Fluorescent Cholangiography for Visualization of Extrahepatic Biliary Anatomy in Emergency Cholecystectomy: A Single-Center, Randomized, Controlled, Parallel-Group Study
- ClinicalTrials.gov ID
- NCT04922528
- Acronym / sponsor ID
- VERT / H21-01375
- Conditions
- Cholecystitis, Acute, Acute Cholangitis, Gallstone Pancreatitis, Choledocholithiasis, Cholecystolithiasis, Gallbladder Diseases
- Keywords
- Cholangiography, Indocyanine green, ICG, Fluorescent cholangiography, Biliary Anatomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective randomized controlled trial evaluating the use of a fluorescent dye, indocyanine green (ICG), in the identification of important bile duct anatomy during emergent same-admission cholecystectomy. Participants will be randomized into either the control arm, which uses the standard of care white light during laparoscopy or the intervention arm, which will use ICG fluorescent cholangiography as an adjunct to white light to visualize the biliary anatomy. The investigators hypothesize that the use of fluorescent cholangiography will increase the rates of identification of important biliary anatomy during laparoscopic cholecystectomy. The effectiveness, feasibility, and safety will be compared between the two groups using a post-operative survey form the surgeons will complete prior to exiting the operating room.
Detailed description
Near-infrared fluorescent imaging techniques have shown promise in aiding to delineate and visualize extrahepatic biliary structures. Indocyanine green (ICG) is a water-soluble fluorescent dye that has been shown to improve visualization of biliary anatomy under fluorescent cholangiography. The standard of care for many acute biliary disease conditions, such as acute cholecystitis, remains early laparoscopic cholecystectomy. Even though real-time fluorescent cholangiography using ICG has the potential to enhance the visualization of biliary structures and anatomy, and therefore reduce the risk for bile duct injury, the majority of the studies published to date exclude acute biliary disease patients. The pathophysiology of acute biliary disease processes is associated with inflammation and adhesions that increase the challenge of achieving a critical view of safety. The investigators propose that using ICG and fluorescent cholangiography near-infrared imaging techniques as an adjunct in acute care laparoscopic cholecystectomies has the potential to help mitigate the increased risk of bile duct injury by increasing extrahepatic biliary structure detection and surgeon confidence.
Eligible patients will be identified through their initial clinical evaluation, which will be verified by the patient's primary surgeon. If and once a patient has been confirmed as eligible, the surgeon or designate will introduce the clinical trial design in detail. If after being introduced to the study and having had the opportunity to ask questions, the patient is willing to participate, the patient will be asked to review and sign the informed consent document.
Upon entry into the clinical trial, the allocation sequence will be generated using a block randomization schema with computer-generated random numbers in a 1:1 ratio, with block sizes of 4 by a co-investigator with no clinical involvement in the trial. The same co-investigator will prepare sequentially numbered, opaque, sealed and stapled envelopes and stored them in a locked cabinet in the operating room control desk. Each envelope contained instructions for the arm the participant had been randomly assigned to, either treatment (ICG cholangiography) or control (standard white light only) arms. After the research team member has obtained the participant's consent, the surgeon or designates will obtain the next consecutively numbered envelope and proceed to open it after the patient is anesthetized and prior to beginning the surgery.
The patient will be blinded to the result of the randomization until after surgery as the envelope will be opened only after the patient has received their general anesthetic. No blinding of the surgical team, research team members or outcomes assessors will be used in this study given the procedural nature and acute condition of the patients included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The intervention and comparator arms will be ran in parallel, with a block randomization sequence determining the participants allocations.
| Arm | Type | Receives |
|---|---|---|
| Near-Infrared Fluorescence Cholangiography | Experimental | Procedure: Laparoscopic Cholecystectomy with Fluorescent Cholangiography, Procedure: Laparoscopic Cholecystectomy with White Light ImagingStandard laparoscopic cholecystectomy completed with a combination of white light imaging and near-Infrared fluorescence cholangiography after administering 5 mg of a 25 mg/10 mL solution of indocyanine green (ICG) intravenously prior to the operation |
| White Light Imaging | Active comparator | Procedure: Laparoscopic Cholecystectomy with White Light ImagingStandard laparoscopic cholecystectomy completed with only standard white light imaging only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admission or consultation by the Acute Care Surgery (ACS) service
- Diagnosis of acute biliary disease requiring index laparoscopic cholecystectomy
- Diagnoses of acute cholangitis, choledocholithiasis, and gall stone pancreatitis may be included. However, they must have cleared ducts confirmed via endoscopic ultrasound, ultrasound, ERCP, and/or laboratory investigations.
- Ability to understand and follow study procedures and protocols, and provide signed informed consent.
Key exclusion criteria (4 listed)
- Female patients who are pregnant or currently breastfeeding
- Known pre-existing liver disease, including cirrhosis
- Known allergy to iodine or shellfish
- Known allergy to indocyanine green (ICG)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Cholecystectomy with Fluorescent CholangiographyIndocyanine green is a fluorophore molecule which is metabolized by the liver and excreted exclusively through the biliary system. Intra-operatively, near-infared imaging via the laparoscope will be used to visualize the biliary anatomy in the intervention arm, as an adjunct to standard of care white-light imaging. | Procedure or surgery | Near-Infrared Fluorescence Cholangiography |
| Laparoscopic Cholecystectomy with White Light ImagingAs per the current standard of care, patients undergoing laparoscopic cholecystectomies will have it completed using white light imaging through the laparoscope. | Procedure or surgery | Near-Infrared Fluorescence Cholangiography, White Light Imaging |
Primary outcome
Detection rate of extrahepatic biliary structures
Time frame: Intraoperatively
The extrahepatic biliary structures which we will be assessing the identification of include: Cystic Duct (CD), Right Hepatic Duct (RHD), Common Hepatic Duct (CHD), Common Bile Duct (CBD), Cystic Duct - Gall Bladder junction (CD-GB), and Cystic Duct - Common Bile Duct junction (CD-CBD).
4 secondary outcomes
Operative success
Time frame: Intraoperatively
Rates of conversion
Time frame: Intraoperatively
Operative time
Time frame: Intraoperatively
Surgeon satisfaction
Time frame: Through participant discharge, an average of 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Background: PubMed 27151917Zroback C, Chow G, Meneghetti A, Warnock G, Meloche M, Chiu CJ, Panton ON. Fluorescent cholangiography in laparoscopic cholecystectomy: the initial Canadian experience. Am J Surg. 2016 May;211(5):933-7. doi: 10.1016/j.amjsurg.2016.01.013. Epub 2016 Feb 23.
- Background: PubMed 31744398Bleszynski MS, DeGirolamo KM, Meneghetti AT, Chiu CJ, Panton ON. Fluorescent Cholangiography in Laparoscopic Cholecystectomy: An Updated Canadian Experience. Surg Innov. 2020 Feb;27(1):38-43. doi: 10.1177/1553350619885792. Epub 2019 Nov 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Philip Dawe, CD MD FRCSC principal investigator
Clinical Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Cholecystectomy with Fluorescent Cholangiography and Laparoscopic Cholecystectomy with White Light Imaging in people with Cholecystitis, Acute and Acute Cholangitis, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karan J D'Souza, MD MPH MM (6048755094, karan.dsouza@alumni.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of extrahepatic biliary structures (time frame: Intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04922528, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.